Peripheral Nerve Pain? There’s a New FDA Approved Device for That

A new implantable neuromodulation device is FDA approved to treat peripheral nerve pain, according to Bioness, Inc.

The device, called the StimRouter Neuromodulation System, is “the only implantable neuromodulation device indicated and marketed to treat chronic pain of peripheral nerve origin,” Bioness stated in a press release. It’s designed to treat peripheral pain in the upper and lower limbs, entrapment syndromes, intercostal neuralgias and other peripheral injuries or diseases.

“StimRouter is an exciting and novel technology which has the potential to benefit many thousands of patients with chronic pain. The product is extremely versatile, minimally invasive and will expand the use of neuromodulation outside traditional patient populations,” said Nagy Mekhail, MD, PhD, who performed the procedure at the Cleveland Clinic.

The device uses both implanted components and externally worn components. An External Pulse Transmitter (EPT) sends electrical signals through the skin to the implanted StimRouter lead. The transmitter can store different stimulation programs for a variety of treatment options depending on patients’ activity and/or pain level. It attaches to a disposable patch, which transmits stimulation through the patch’s gel electrodes. A handheld remote control allows patients to change programs and alter how stimulation is delivered.

The implantation process begins with a stimulation probe that doctors use to identify the targeted peripheral nerves. A stimulating electrode lead is then inserted at the target site and stimulation is delivered to verify pain relief. Attached to the electrode lead is the devices receiver.

“We are motivated to expand the frontier of neuromodulation and change the status quo,” stated Todd Cushman, President and CEO of Bioness. “The Bioness Team is focused on expanding StimRouter accessibility through a methodical clinical training program with special focus on our principal commercial markets.”